Method of using collection device

ABSTRACT

A biological fluid collection device with a pivotable faucet is disclosed. The device is designed to collect, hold and transfer a biological specimen into a non-evacuated tube through an integrated pivotable faucet component. This device uses no needles, either blunt or sharp, and provides safety from needle puncture. The device works with a non-evacuated tube and a specially designed cap that attaches to the container via the pivotable faucet. The device includes a container for collecting, holding and transferring the biological fluid. The design of the container facilitates use of the tube as a handle in order to position the container to receive collection of the biological fluids. The method of collection begins with using the non-evacuated tube as a handle to hold the container and collecting the biological specimen in the container. A lid is attached to the top of the container to prevent contamination and exposure to the specimen during transfer into the non-evacuated tube. The non-evacuated tube is rotated and stopped in place by a detent. The transfer of the biological fluid is without any contact to the liquid specimen. Gravity allows the liquid to transfer. Liquid transfer is stopped by rotation of the tube and pivotable faucet. The tube is rotated back to its original position as a handle and pulled off the container. The second tube may be filled at that time or the container can be discarded for proper disposal.

RELATED APPLICATION

[0001] This application is a continuation of Appl. Ser. No. 09/369,997filed Aug. 6, 1999.

BACKGROUND OF THE INVENTION

[0002] 1. Field of the Invention

[0003] The invention relates generally to an apparatus for collectingand transferring biological fluids. More particularly, the presentinvention relates to a biological fluid collection device with apivotable faucet for collecting and transferring a fluid specimen to acollection tube.

[0004] 2. Description of Related Art

[0005] Biological fluids are collected periodically for laboratoryanalysis. Laboratory equipment that performs the analysis may onlyaccept biological fluids stored in a test tube. However, a test tube istoo small for the convenient collection of many biological fluids, suchas urine. As a result, specimens often are collected in a fairly largecontainer. After collection of the fluid in the container, the containeris delivered to a medical technician. The technician then transfers aportion of the fluid to a collection tube that can be sealed andtransported to a laboratory for analysis. The transfer of biologicalfluid from the collection container to the collection tube is anunpleasant task that creates the risk of contaminating the specimen orexposing the medical technician to potentially harmful pathogens in thespecimen.

[0006] In urine specimen collection, vacuum tubes are usually not veryuseful because vacuum tubes usually have a limited shelf life due to agradual migration of gas molecules through the walls of the tube. Someprior art collection containers have a test tube that is attached. Inthis prior art device, a portion of the specimen in the container isautomatically transferred to the tube. The tube then may be separatedfrom the container, sealed and shipped to a laboratory for analysis.However, these prior art assemblies can lead to leakage during theinitial collection of the specimen or after the separation of the testtube from the collection container. Additionally, control of the volumeof the specimen in the test tube may vary from sample to sample. A meansfor controlling the volume in each specimen sample taken is needed toassure accurate results in the subsequent laboratory analysis. Also, theuse of a non-sharp or blunt cannula in the transfer of the specimen fromthe collection container to the tube is preferred to avoid potentialskin puncturing of the medical technician. A collection containerdesigned to avoid human contact during transfer of the specimen isdesired in order to prevent specimen contamination. Also, there is aneed for a collection container to use a non-evacuated vacuum tube toavoid the potential limited shelf life of the vacuum tube.

SUMMARY OF THE INVENTION

[0007] The present invention alleviates in great part the drawbacksassociated with the prior art biological fluid collection devices.Provided is a biological fluid collection device comprising a containerfor holding the fluid having an upper open portion, a lower portion andside walls therebetween. The container further includes an orificethrough the container at a low gravitational point inside the container.A projecting faucet pivotably attached to the container is alsoprovided. The faucet is in fluid communication with the orifice. Theorifice and faucet can be disposed on either the lower portion or sidewalls. The pivotable faucet has closed and open positions. Because thefaucet has open and closed positions, pivoting or rotation of the faucetcontrols the fluid transfer from the container.

[0008] Further included in the device is a tube having a closed bottom,an open top and side walls therebetween. The tube used in the biologicalfluid collection device is preferably non-evacuated. However, anevacuated tube may be used in this device. The tube further includes acap disposed on the open top. The cap has an off-centered holetherethrough for receiving the pivotable faucet in releasable lockingengagement. Thus, no needles, either blunt or sharp, are used in thetransfer of the fluid from the container to the tube. The cap on thetest tube further includes a closure lid hingedly attached to the capfor permanently sealing the cap after fluid collection. A plug on theclosure lid mates with the hole in the cap to provide a leak-resistantseal.

[0009] The faucet rotates in a closed position when the tube is used asa handle for holding the container during collection. The faucet isrotated in the open position when the fluid flows through the hole intothe tube. When the orifice and pivotable faucet are disposed on thelower portion, the biological fluid collection device can furthercomprise an annular skirt attached to the lower portion. The annularskirt has a planar bottom for flat surface support. The annular skirtfurther includes a recessed portion for securing the tube in the closedposition. Also included in the biological fluid device, when the orificeand faucet are disposed on the lower portion, is a detent mounted on theannular skirt. The purpose for the detent is for securing the tube inthe open position. The detent also has a planar bottom for assisting inflat surface support.

[0010] When the orifice and pivotable faucet are disposed on the sidewalls of the container, the side walls have a recessed portion forsecuring the tube in the closed position. In this embodiment, the lowerportion is substantially planar for providing flat surface support.

[0011] The biological fluid collection device further comprises a liddisposed on the upper portion of the container for protecting the fluidin the container from contamination. The lid on the biological fluidcollection device further comprises a vent which allows air flow duringthe transfer process to the tube. The vent contains a membrane which isdisposed on the lid. The membrane allows the air flow through the ventand prevents fluid flow through the lid.

[0012] The biological fluid collection device can further includedepressions on the side walls for assisting and gripping the container.The container could also include snap fits mounted to the lower portionto hold the tube during storage.

BRIEF DESCRIPTION OF THE DRAWINGS

[0013] The invention is now described in greater detail by way ofreference to the following drawings wherein:

[0014]FIG. 1 is an exploded front perspective view of the biologicalfluid collection device with a pivotable faucet of the presentinvention.

[0015]FIG. 2 shows an assembled back perspective view of the biologicalfluid collection device in FIG. 1.

[0016]FIG. 3 shows a front view of the biological fluid collectiondevice of FIG. 2.

[0017]FIG. 4 illustrates a side view of the biological fluid collectiondevice of FIG. 2.

[0018]FIG. 5 is an exploded front perspective view of the biologicalfluid collection device in FIG. 2 in conjunction with a tube.

[0019]FIG. 6 is a side view of the biological fluid collection deviceassembled with a tube positioned in the closed position.

[0020]FIG. 7 is a side view of the biological fluid collection deviceassembled with a tube in the open position.

[0021]FIG. 8 is a cross-sectional view of FIG. 6.

[0022]FIG. 9 is a cross-sectional view of FIG. 7.

[0023]FIG. 10 is a perspective view of an alternate embodiment of thebiological fluid collection device in FIG. 6 in the closed position.

[0024]FIG. 11 is a side view of the device in FIG. 10 in the openposition.

DETAILED DESCRIPTION OF THE INVENTION

[0025] Turning now to the drawings, wherein like numerals denote likecomponents, FIGS. 1-11 depict a biological fluid collection device witha pivotable faucet generally shown numeral 8. Device 8 comprises acontainer 10, a tube 40, and a projecting faucet 30. Container 10 is forcollecting, holding, and transferring the fluid. Container 10 has anupper portion 12, a lower portion 14, and side walls 20 therebetween.Preferably, side walls 20 are cylindrically shaped. However, such ashape is not necessary for device 8 to function. Other such shapes forside walls 20 include oblong shaped, elliptical shaped, contouredshaped, and rectangularly shaped side walls. Container 10 furtherincludes an orifice 22 through container 10. Orifice 22 is located at alow gravitational point 24 inside container 10. Low gravitational point24 need not be the lowest gravitational point in container 10 for device8 to function. All that is needed for device 8 to transfer the fluidwithin is that orifice 22 is at a low gravity point.

[0026] Projecting faucet 30 is pivotably attached to container 10 and influid communication with orifice 22. Pivotable faucet 30 has a closedposition 32 and an open position 34 as shown in FIGS. 6 and 7,respectively. Orifice 22 and pivotable faucet 30 are preferably disposedon lower portion 14. However, orifice 22 and pivotable faucet 30 may bedisposed on side walls 20 as shown in FIGS. 10 and 1 1.

[0027] Pivotable faucet 30 is further characterized as shown in FIG. 5to include a conduit 36 therethrough, a male distal end 38 and aproximal end 39. Male distal end 38 attaches to a cap 52 on tube 40. Cap52 has a hole 54 which male distal end 38 enters into for secure andreleasable attachment. Hole 54 is off-centered to provide maximumclearance for attachment of tube 40 to container 10 and for tube 40 topivot. Thus, no needle cannula, either sharp or blunt, is required forthe transfer of fluid from container 10 to tube 40. Preferably, tube 40is attached to container 10 prior to collection. However, tube 40 doesnot have to be connected to container 10 for device 8 to function. Iftube 40 is not attached to container 10 during collection, faucet 30must be in closed position 32, otherwise fluid comes out of male distalend 38. Thus, after tube 40 is removed from container 10 when transferis completed, fluid will leak out unless faucet is placed in closedposition 32. This attachment is seen in FIG. 8 and FIG. 9. Faucet 30also has a pivot point 35. When faucet 30 is pivoted about point 35 andconduit 36 at proximal end 39 is in fluid communication with orifice 22,faucet 30 is opened and fluid transfer from container 10 commences.Conversely, when faucet 30 is pivoted so that conduit 36 at proximal end39 is not in fluid communication with orifice 22, faucet 30 is closedand no fluid transfer commences. Thus, pivotable faucet 30 controls theamount of fluid that is transferred out of container 10.

[0028] Tube 40 as shown in FIGS. 5-9 is further included in device 8.Tube 40 is characterized by a closed bottom 42, an open top 44 andcylindrical side walls 50 therebetween. Preferably, tube 40 is anon-evacuated tube for collection purposes. However, an evacuated tubemay be used. A non-evacuated tube is preferred because there is noshelf-life for the vacuum which pulls the fluid in the tube. In thepresent invention, gravity pulls the fluid from container 10 into tube40. Tube 40 further includes cap 52 disposed on open top 44. There aremany methods for cap 52 to be disposed on open top 44. Such methodsinclude thread attachment, snap-fittings, and mechanical fasteners.

[0029] Hole 54 is through cap 52 for receiving male distal end 38 offaucet 30 in releasably locking engagement. Hole 54 is off-centered withrespect to the center point of cap 52. The function of this geometry isto provide maximum clearance for tube 40 to pivot when tube 40 isconnected to faucet 30. Faucet 30 is in closed position 32 when tube 40is perpendicular to container 10. Tube 40 is then used as a handle 60for holding container 10 during collection. Faucet 30 is rotated in openposition 34 when fluid flows through hole 54 into tube 40. Rotation offaucet 30 is enabled by pivoting tube 40.

[0030] Lower portion 14 is characterized by an annular skirt 16. Annularskirt 16 is attached to the bottom of lower portion 14. Preferably, inthis embodiment, annular skirt 16 and lower portion 14 are a unitarystructure and made of the same material. However, both may be separatecomponents mounted together. Methods for mounting include ultra-sonicwelding, adhesive bonding, and mechanical fasteners. Annular skirt 16 isfurther characterized by having a planar bottom 18 for flat surfacesupport. Thus, device 8 can be placed on a flat surface without tippingover. Annular skirt 16 is also characterized by having a recessedportion 62 for securing tube 40 in closed position 32.

[0031] A detent 64 is further included on annular skirt 16. Detent 64 ismounted on the back end of annular skirt 16 opposite recessed portion 62for securing tube 40 in open position 34. Detent 64 has a planar bottom19 for flat surface support with planar bottom 18 of annular skirt 16.Such structures are shown in FIG. 4. The function of detent 64 is toprevent further backward motion of tube 40 when pivoted into openposition 34. Detent 64 also provides support to tube 40 when in openposition 34.

[0032] Annular skirt 16 is further characterized by having an open area65 adjacent to detent 64. Open area 65 is preferably rectangular inshape but is not limited to such a shape for device 8 to function. Othersuch shapes include semi-circles, triangles and elliptical shapes. Arectangular shape is preferred for open area 65 so that side walls 50 oftube 40 creates a frictional fit on the inner walls of open area 65.This frictional fit assists in the stability of tube 40 during transfer.Open area 65 also functions as a space for tube 40 to sit when inposition 34.

[0033] Alternatively, orifice 22 and pivotable faucet 30 are disposed ona side wall 120 as shown in FIGS. 10 and 11. In this alternateembodiment, side wall 120 is further characterized by having a recessedportion 63 for securing tube 40 in a closed position 142 as shown inFIG. 10. This alternate embodiment is generally described as a container110. Container 110 has a storage lid 94 disposed thereon.

[0034] Container 110 is characterized by an upper portion 112, a lowerportion 114 and oblong side walls 120 therebetween. Storage lid 94 isdisposed on upper portion 112. Preferably, storage lid 94 is a wovenpolyethylene material heat sealed on upper portion 112. However, storagelid 94 can be made of various thermoplastics. Such materials includepolyethylene, styrene, polypropylene and polyester. Other attachmentmethods include snap fits, adhesive bonding and mechanical fasteners.

[0035] Lower portion 114 is characterized by having a substantiallyplanar bottom 70 for providing flat surface support for container 110.Lower portion 114 further includes an array of snap fits 92 as shown inFIG. 10. The function of snap fits 92 is to hold tube 40 when container110 is in storage prior to use. Preferably, snap fits 92 and container110 are a unitary structure. However, snap fits 92 can be a separatecomponent and be attached to lower portion 114 by several methods knownto those skilled in the art. Such methods include heat welding, adhesivebonding, mechanical fasteners, ultrasonic welding, and snap fittings.

[0036] Side walls 120 is characterized by having a pair of depressions90 as shown in FIG. 10 and FIG. 11. Depressions 90 allow the user toergonomically and safely grasp container 110 without contaminating thefluid specimen inside.

[0037] In the preferred embodiment shown in FIGS. 1-9, container 10 hasa lid 72 disposed on upper portion 12 for protecting the fluid incontainer 10 from contamination. In the alternate embodiment shown inFIGS. 10-11, storage lid 94 is disposed on upper portion 112 forprotecting the contents inside container 110 prior to use. Such contentsinclude tube 40 in snap fits 92. Unlike protective lid 72, storage lid94 is not re-attached after collection. Protective lid 72 is placed onupper portion 12 after the specimen collection has been taken.

[0038] Protective lid 72 is further characterized by having at least oneinternal projection 82 for lockingly engaging at least one externalprojection 80 on side wall 20. External projection 80 is adjacent toupper portion 12. Preferably, internal projection 82 and externalprojection 80 are matching threads. However, it is within the purview ofthe invention for internal projection 82 and external projection 80 tobe matching snap fits, or mechanical fasteners. In addition, internalprojection 82 may be on side walls 20 and external projection 80 may beon lid 72.

[0039] When protective lid 72 is disposed on upper portion 12, apermanent and leak-resistant seal is formed. This seal preventsre-opening of lid 72 after collection of the biological fluid incontainer 10. The leak-resistant seal enables container 10 to providesafety from leaks or spills when the fluid is transferred into tube 40.After transfer, tube 40 is transported to the laboratory instead ofcontainer 10. Lid 72 provides protection from the biological fluidinside container 10 and protects the fluid specimen from contamination.

[0040] Protective lid 72 is further characterized by a plurality of ribs73 circumferentially disposed on the edges of lid 72. Side walls 20further includes a plurality of vertical ribs 21 also circumferentiallydisposed around the outside of container 10 adjacent to upper portion12. The function of ribs 73 and vertical ribs 21 is to allow gripping oflid 72 and container 10 when attaching to form the permanent and leakresistant seal between lid 72 and container 10.

[0041] Cap 52 is further characterized by comprising a closure lid 74hingedly attached to cap 52 for permanently sealing cap 52 after fluidcollection. Closure lid 74 further includes a plug 75 off-centered fromthe center point of closure lid 74 to attach inside off-centered hole 54of cap 52. A hinge 76 attaches closure lid 74 to cap 52. When plug 75attaches to hole 54, a permanent and leak-resistant seal is formed. Tube40 with transferred fluid from container 10 is transported to alaboratory for analysis with this safety feature which resists leakingor spilling fluid. There are many methods plug 75 can attach to hole 54.Such methods include matching snap fits, mechanical fasteners andlatches known to those skilled in the art.

[0042] As shown in FIGS. 8 and 9, protective lid 72 it is furthercharacterized by including a vent 84 for allowing air flow therethrough.Vent 84 includes an orifice 85. Fluid and air can penetrate orifice 85.A membrane 86 is disposed on the top of lid 72 to facilitate air flowfrom vent 84 during collection. Membrane 86 prevents fluid from escapingor penetrating while allowing air to permeate. Membrane 86 is disposedon lid 72 rather than in vent 84 to provide maximum air flow throughorifice 85 and vent 84. Fluid is prevented from flowing through the restof the lid 72 by membrane 86.

[0043] Operation of biological fluid collection device 8 begins withcollecting a specimen in container 10. Collection can occur with orwithout collection tube 40 attached because pivotable faucet 30 has aclosed position 32. Preferably, test tube 40 is attached to container 10so that test tube 40 can be used as handle 60 during the collectionprocess. After collection has taken place, protective lid 72 is disposedon upper portion 12 to prevent contamination and exposure to thespecimen in container 10. Tube 40, if not attached, is attached to thecontainer 10 by inserting hole 54 over male distal end 40 in releasablylocking engagement. Male distal end 40 has a luer taper to match withhole 54 which has a corresponding taper. In closed position 32, closedbottom 42 of test tube 40 is perpendicular to container 10. Rotation oftube 40 towards recessed portion 62 allows pivotable faucet 30 to be inopen position 34. In open position 34, closed bottom 42 of tube 40 islower than lower portion 14 and fluid begins to flow through hole 54 andinto tube 40. Once a sufficient amount of specimen has been transferredinto tube 40, tube 40 is then rotated back into closed position 32. Inclosed position 32, no fluid is transferred from container 10. Tube 40is then removed from pivotable faucet 30 and closure lid 72 is rotatedon cap 52 such that plug 75 enters hole 54 for permanent andleak-resistant sealing. At this point, tube 40 is ready to be shipped toa laboratory for further analysis. Another tube may be attached tocontainer 10 in a similar manner if more specimen samples are desired.

[0044] Test tube 40 can also be used with alternate collection container110 as shown in FIGS. 10 and 11. Container 110 includes orifice 22through side walls 120 at a low gravitational point inside container110. Side walls 120 has recessed portion 63 for supporting tube 40 inclosed position 142. Like the preferred embodiment, this alternateembodiment allows tube 40 to be used as a handle during the collectionprocess. Container 110 is further characterized by having snap fits 92mounted to lower portion 114 to hold tube 40 thereon during storage.Storage lid 94 is disposed over upper portion 112 and is removed beforecollection commences. Storage lid 94 is not replaced on upper portion112 after the collection process has been completed. Side walls 120further includes depressions 90 for assisting and gripping container110.

[0045] Pivotable faucet 30, as shown in FIGS. 10 and 11, is rotated intoclosed position 142 and into recessed portion 63 when closed bottom 42of tube 40 is above upper portion 112. Tube 40 again can be used as ahandle for container 110 during collection. After collection, pivotablefaucet 30 is rotated away from recessed portion 63 in an open position144. Open position 144 is shown when closed bottom 42 of tube 40 islowered for the fluid to flow through hole 54 and transfer into tube 40.Tube 40 can be rotated back into closed position 142 after the desirevolume is transferred into tube 40. Tube 40 is removed and subsequentlysealed by closure lid 74, similar to the preferred embodiment, fortransport to a laboratory for analysis. At that point, another tube canbe attached to container 110 if further specimen samples are desired.For both embodiments, it is preferred not to have faucet 30 in openposition 34 or open position 144 during collection. Both embodimentspreferably should have faucet 30 in closed position 32 or closedposition 142 during collection in container 10 or container 110. Thisprocedure is preferred because it reduces the risk of specimen leaks orspills during collection. During transfer into tube 40, faucet 30 isopened.

[0046] The embodiments depicted in FIGS. 1-11 are intended to merely beexemplary. They are not intended to depict all possible collectioncontainers. Rather, pivotable faucet 30 and tube 40 can be used with anycontainers having the appropriate dimensions for mating male distal end38 into hole 54. Pivotable faucet 30 can also be used in any desiredangle of orientation. The present invention is able to control thevolume of specimen transferred into tube 40 by pivotable faucet 30without creating a potential for leakage or spills and without the useof blunt or sharp cannula. Thus, the present invention improves thesafety and transfer control in biological fluid collection devices byeliminating the use of piercing members and controlling the transfer ofthe biological fluid by a pivotable faucet.

What is claimed is:
 1. A method for collecting biological fluidscomprising: providing a first container having a substantially closedbottom and a top that is at least partly open, a pivotable faucet beingmounted in said closed bottom and being pivotable between a closedposition and an open position; providing a second container having aclosed bottom and a top that is at least partly open; placing said opentop of said second container in communication with said faucet of saidfirst container; collecting the biological fluid in the first containerwhile said faucet is in said closed position; pivoting said faucet andsaid second container connected thereto into said open position of saidfaucet for permitting a transfer of at least a portion of the biologicalfluid from said first container to said second container; pivoting saidfaucet and said second container to said closed position of said faucet;and separating said second container from said faucet.
 2. The method ofclaim 1, further comprising the step of closing said open top of saidsecond container after separating said second container from saidfaucet.
 3. The method of claim 2, wherein a cap is hingedly connected tosaid second container, said step of closing said second containercomprising hingedly rotating said cap into sealed engagement with saidopen top of said second container.
 4. The method of claim 1, whereinsaid faucet comprises a male distal end projecting from said firstcontainer and wherein said top of said second container defines anopening configured for fluid tight engagement with said male distal endof said faucet.
 5. The method of claim 1, further comprising the step ofproviding a fluid tight seal over said open top of said first containerafter collecting said fluid specimen in said first container.
 6. Themethod of claim 1, wherein said second container is a tube and projectstransversely beyond said first container when said second container isplaced in communication with said faucet and when said faucet is in saidclosed position, said method comprising the step of holding said secondcontainer for supporting both said first and second containers while thebiological fluid is being collected in said first container.
 7. Themethod of claim 1, wherein the second container is dimensioned andconfigured for placement in said first container, said method comprisingstoring said second container in said first container prior tocollection of said biological fluid specimen, removing said secondcontainer from said first container prior to placing said open top ofsaid second container in communication with said faucet.
 8. The methodof claim 1, wherein the first and second containers each have topclosures mounted on the respective first and second containers forsterility prior to use, said method comprising removing the first andsecond closures prior to collecting said biological fluid; placing saidclosure on said first container after collecting said biological fluidand before pivoting said faucet into said opened position and closingsaid second container after separation of said second container fromsaid first container to said second container.
 9. A method forcollecting biological fluids, comprising: providing a container having asubstantially closed bottom and a top with a removable cover, apivotable faucet being mounted in said substantially closed bottom andbeing pivotable between a closed position and an open position;providing a test tube having a closed bottom and a top, a cap beingremovably engaged with said top for selectively opening said test tube;removing said cover of said container; placing said top of said testtube in communication with said faucet of said container; collecting thebiological fluid in said first container while said faucet is in saidclosed position; replacing said cover on said top of said container;pivoting said faucet and said test tube connected thereto into said openposition of said faucet for permitting a transfer of a portion of thebiological fluid from said container to said test tube; pivoting saidfaucet and said test tube to said closed position of said faucet;separating said test tube from said faucet; and replacing said cap onsaid top of said test tube.